Amicus Therapeutics and GlaxoSmithKline have revised their Fabry agreement under which Amicus obtains global rights to develop and commercialize the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
Amicus will have sole rights to the global drug development, regulatory and commercial activities for the next-generation Fabry ERT (migalastat HCl co-formulated with ERT), as well as migalastat HCl monotherapy. GSK will be eligible for future regulatory and commercial milestones, as well as royalties on sales. Additionally, GSK will invest $3 million in Amicus through an equity investment transaction.
Under the prior agreement from July 2012, Amicus and GSK were co-developing migalastat HCl globally and GSK had rights to commercialize migalastat HCl outside the U.S.
Moncef Slaoui, chairman of GSK R&D, said, "With internal expertise and established relationships within the rare disease community, we believe Amicus is well positioned to maintain momentum of the programs, maximizing their potential for success, which we hope will provide benefits to patients living with Fabry disease. GSK will continue to support Amicus through our equity investment and share in the future value of migalastat HCl as the Fabry program meets certain regulatory and sales milestones."
John F. Crowley, chairman and chief executive officer of Amicus Therapeutics, Inc., said, "This transaction is very important for Amicus and for our future. It delivers what we believe to be immediate and significant value to our shareholders while allowing us to maintain a strong relationship with GSK, our largest shareholder. With this transaction we are gaining worldwide rights to our first proprietary next generation co-formulated product, as well as migalastat HCl monotherapy. We look forward to advancing these programs to major milestones into 2014."